Overview
Famotidine is a competitive histamine-2 (H) receptor antagonist that works to inhibit gastric acid secretion. It is commonly used in gastrointestinal conditions related to acid secretion, such as gastric ulcers and gastroesophageal reflux disease (GERD), in adults and children. Compared to other H receptor antagonists, famotidine displays high selectivity towards this receptor; in a study consisting of healthy volunteers and patients with acid hypersecretory disease, famotidine was about 20 to 50 times more potent at inhibiting gastric acid secretion than cimetidine and eight times more potent than ranitidine on a weight basis. Famotidine is used in various over-the-counter and off-label uses. While oral formulations of famotidine are more commonly used, the intravenous solution of the drug is available for use in hospital settings.
Indication
Famotidine is indicated in pediatric and adult patients (with the bodyweight of 40 kg and above) for the management of active duodenal ulcer (DU), active gastric ulcer, symptomatic non-erosive gastroesophageal reflux disease (GERD), and erosive esophagitis due to GERD, diagnosed by biopsy. It is also indicated in adult patients for the treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine neoplasias) and reduction of the risk of DU recurrence. The intravenous formulation of famotidine is available for some hospitalized patients with pathological hypersecretory conditions or intractable ulcers or as an alternative to the oral dosage form for short-term use in patients who are unable to take oral medication. Over-the-counter famotidine is used for the management and prevention of heartburn caused by gastroesophageal reflux in children and adults. Off-label uses of famotidine include the reduction of NSAIDs-associated gastrointestinal effects, treatment of refractory urticarial, prevention of stress ulcer in critically-ill patients, and symptomatic relief of gastritis.
Associated Conditions
- Chronic Back Pain
- Duodenal Ulcer
- Erosive Esophagitis
- Extra-Articular Rheumatism
- Gastritis
- Heartburn
- Helicobacter Pylori Infection
- Multiple Endocrine Neoplasia
- Muscle Spasms
- Nonspecific Pain Post Traumatic Injury
- Osteoarthritis (OA)
- Postoperative pain
- Stress Ulcers
- Symptomatic Non-erosive Gastroesophageal Reflux Disease
- Zollinger-Ellison Syndrome
- Active Gastric ulcer
- Acute Duodenal Ulcers
- Gastrointestinal ulceration
- Pathological hypersecretory conditions
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/08/03 | Not Applicable | Not yet recruiting | |||
2025/06/12 | Phase 1 | Recruiting | |||
2025/02/28 | Phase 1 | Completed | |||
2025/02/11 | Phase 2 | Recruiting | |||
2024/12/19 | Phase 4 | Not yet recruiting | Kim, Young Sung | ||
2024/03/27 | Phase 1 | ENROLLING_BY_INVITATION | |||
2024/02/20 | Phase 1 | Completed | Noha Mansour | ||
2024/02/05 | Phase 4 | Recruiting | |||
2024/01/19 | Phase 1 | Recruiting | |||
2024/01/18 | Not Applicable | Completed | Aswan University Hospital |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| PD-Rx Pharmaceuticals, Inc. | 72789-453 | ORAL | 40 mg in 1 1 | 4/8/2025 | |
| Mylan Institutional LLC | 67457-457 | INTRAVENOUS | 10 mg in 1 mL | 12/5/2018 | |
| Redpharm Drug | 67296-2133 | ORAL | 20 mg in 1 1 | 6/10/2025 | |
| Unit Dose Services | 50436-7371 | ORAL | 20 mg in 1 1 | 11/12/2012 | |
| Bryant Ranch Prepack | 63629-7013 | ORAL | 20 mg in 1 1 | 5/30/2019 | |
| Praxis, LLC | 59368-333 | ORAL | 20 mg in 1 1 | 1/1/2023 | |
| Bryant Ranch Prepack | 63629-1013 | ORAL | 20 mg in 1 1 | 5/30/2019 | |
| Ascent Pharmaceuticals, Inc. | 43602-502 | ORAL | 40 mg in 1 1 | 10/22/2021 | |
| HF Acquisition Co LLC, DBA HealthFirst | 51662-1375 | INTRAVENOUS | 10 mg in 1 mL | 10/1/2022 | |
| AvPAK | 50268-304 | ORAL | 40 mg in 1 1 | 1/9/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| FAMOTIN TABLET 40 mg | SIN07568P | TABLET | 40 mg | 12/6/1993 | |
| PHARMA FAMOTIDINE TABLET 20 mg | SIN10470P | TABLET, FILM COATED | 20 mg | 11/27/1998 | |
| FAMODINE TABLET 20 mg | SIN09129P | TABLET | 20 mg | 1/15/1997 | |
| FAMOC 40 TABLET 40 mg | SIN10291P | TABLET, FILM COATED | 40 mg | 10/26/1998 | |
| SUNPEPCIN 40 TABLET 40 mg | SIN10596P | TABLET, FILM COATED | 40 mg | 12/31/1998 | |
| FEBCID-40 TABLET 40 mg | SIN12039P | TABLET, FILM COATED | 40 mg | 7/31/2002 | |
| FAMOTIDINE FILM COATED TABLET 40 mg | SIN10209P | TABLET, FILM COATED | 40.00 mg | 10/8/1998 | |
| FAMOTIN TABLET 20 mg | SIN07569P | TABLET | 20 mg | 12/6/1993 | |
| SUNPEPCIN 20 TABLET 20 mg | SIN10595P | TABLET, FILM COATED | 20 mg | 12/31/1998 | |
| FAMOC 20 TABLET 20 mg | SIN10292P | TABLET, FILM COATED | 20 mg | 10/26/1998 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| DIGESTONE TAB 40MG | N/A | N/A | N/A | 5/18/2001 | |
| FAMOL TAB 40MG | N/A | N/A | N/A | 7/28/2001 | |
| FAMOSIA TABLETS 20MG | N/A | N/A | N/A | 6/7/2017 | |
| FAMOLTA TAB 20MG | N/A | N/A | N/A | 6/18/2001 | |
| GARADINE TAB 20MG | N/A | N/A | N/A | 8/24/2001 | |
| FAMOTIDINE TABLETS 20MG | N/A | N/A | N/A | 5/13/2015 | |
| WAHTATNIN TABLETS 20MG | N/A | N/A | N/A | 2/24/2020 | |
| VESMO TABLETS 20MG | N/A | N/A | N/A | 8/31/2023 | |
| YAMADIN-20 TAB 20MG | N/A | N/A | N/A | 3/5/2007 | |
| ULMO-20 TAB 20MG | N/A | N/A | N/A | 10/31/1997 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| AUSFAM 20 famotidine 20mg tablet blister pack | 423710 | Medicine | A | 1/24/2024 | |
| ARFAM 40 famotidine 40mg tablet blister pack | 93767 | Medicine | A | 4/2/2003 | |
| FAMOTIDINE DWRN famotidine 40mg tablet blister pack | 428031 | Medicine | A | 1/22/2024 | |
| FAMOTIDINE RJIC famotidine 40mg tablet blister pack | 423670 | Medicine | A | 1/22/2024 | |
| FAMOTIDINE TIH famotidine 40mg film-coated tablet blister pack | 384188 | Medicine | A | 5/27/2022 | |
| ARFAM 20 famotidine 20mg tablet blister pack | 93764 | Medicine | A | 4/2/2003 | |
| AUSFAM 40 famotidine 40mg tablet blister pack | 93789 | Medicine | A | 4/8/2003 | |
| FAMOTREN famotidine 40mg film-coated tablet blister pack | 186276 | Medicine | A | 6/25/2012 | |
| FAMOTIDINE DWRN famotidine 20mg tablet blister pack | 423311 | Medicine | A | 1/22/2024 | |
| PEPTRIS famotidine 20mg film-coated tablet blister pack | 186278 | Medicine | A | 6/25/2012 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| FAMOTIDINE IV INJECTION | teva canada limited | 02247799 | Solution - Intravenous | 10 MG / ML | N/A |
| FAMOTIDINE TABLETS | ivax pharmaceuticals incorporated | 02248222 | Tablet - Oral | 20 MG | N/A |
| PEPCID COMPLETE | mcneil consumer healthcare division of johnson & johnson inc | 02243053 | Tablet (Chewable) - Oral | 10 MG | 5/14/2001 |
| PEPCID AC (CHEWABLE TAB) - 10MG | Merck Canada Inc | 02185911 | Tablet - Oral | 10 MG | 4/25/1997 |
| MYLAN-FAMOTIDINE | Mylan Pharmaceuticals ULC | 02196026 | Tablet - Oral | 40 MG | 12/31/1995 |
| AURO-FAMOTIDINE 10 MG | auro pharma inc | 02545802 | Tablet - Oral | 10 MG | N/A |
| FAMOTIDINE IV INJECTION | teva canada limited | 02247800 | Solution - Intravenous | 10 MG / ML | N/A |
| FAMOTIDINE INJECTION | hospira healthcare ulc | 02246364 | Solution - Intravenous | 10 MG / ML | N/A |
| TEVA-FAMOTIDINE | teva canada limited | 02022133 | Tablet - Oral | 20 MG | 12/31/1993 |
| RATIO-FAMOTIDINE 20MG | ratiopharm inc division of teva canada limited | 02242327 | Tablet - Oral | 20 MG | 7/11/2000 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| FAMOTIDINA CINFA 20 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorios Cinfa S.A. | 63319 | COMPRIMIDO RECUBIERTO | Medicamento Sujeto A Prescripción Médica | Commercialized |
| FAMOTIDINA ARISTO 20 mg COMPRIMIDOS EFG | Aristo Pharma Iberia S.L. | 63712 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
| FAMOTIDINA ARISTO 40 mg COMPRIMIDOS EFG | Aristo Pharma Iberia S.L. | 63713 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
| FAMOTIDINA NORMON 20 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG | Laboratorios Normon S.A. | 66093 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| FAMOTIDINA CINFA 40 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorios Cinfa S.A. | 63317 | COMPRIMIDO RECUBIERTO | Medicamento Sujeto A Prescripción Médica | Commercialized |
| FAMOTIDINA NORMON 40 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG | Laboratorios Normon S.A. | 66094 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| FAMOTIDINA MABO 40 mg COMPRIMIDOS EFG | Mabo Farma S.A. | 58473 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
| FAMOTIDINA MABO 20 mg COMPRIMIDOS EFG | Mabo Farma S.A. | 58472 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
| PEPCID 10 mg COMPRIMIDOS RECUBIERTOS | Jntl Consumer Health (Spain) S.L. | 62090 | COMPRIMIDO RECUBIERTO | Sin Receta | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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